Coaching for Caregivers of Children With Spinal Cord Injury

• ClinicalTrials.gov Identifier: NCT03898700
• Recruitment Status: Completed
• First Posted: April 2, 2019
• Results First Posted: April 18, 2023
• Last Update Posted: April 18, 2023
• Sponsor: Thomas Jefferson University
• Information provided by (Responsible Party): Thomas Jefferson University

Tracking Information

• First Submitted Date: January 22, 2019
• First Posted Date: April 2, 2019
• Results First Submitted Date: April 14, 2021
• Results First Posted Date: April 18, 2023
• Last Update Posted Date: April 18, 2023
• Actual Study Start Date: September 28, 2018
• Actual Primary Completion Date: November 16, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 17, 2023)

Change in Canadian Occupational Performance Measure (COPM) [ Time Frame: Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline) ]

Rates self perceived performance and satisfaction with self-identified goals on a 10 point likert scale (1 cannot do, not satisfied; 10 can do without a problem, very satisfied). A 2-point change is considered clinically meaningful.

Original Primary Outcome Measures (submitted: March 29, 2019)

Change in Canadian Occupational Performance Measure [ Time Frame: Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline) ]

Rates self perceived performance and satisfaction with self-identified goals on a 10 point likert scale (1 cannot do, not satisfied; 10 can do without a problem, very satisfied). A 2-point change is considered clinically meaningful. We will also use participant anchors to determine success.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Coaching for Caregivers of Children With Spinal Cord Injury
• Official Title: Coaching in Context for Caregivers of Children With Spinal Cord Injury
• Brief Summary: This pilot study has two aims. The first aim is to establish the feasibility of coaching for caregivers of youth with spinal cord injury, and the second aim is to establish methodological procedures for a future multi-center study on the effectiveness of coaching as an intervention for caregivers of youth with spinal cord injury.
• Detailed Description: This study addresses the unmet needs of female primary informal caregivers of youth with spinal cord injury. A one-group pre-post treatment design will be used. Consented caregivers will receive coaching via face-to-face or via the phone. Each caregiver will participate in up to 10 coaching sessions. Each coaching session will last up to 90 minutes. Coaching sessions will be audiorecorded and transcribed verbatim. Outcomes of coaching on caregivers' self-identified goals will be assessed using the Canadian Occupational Performance Measure.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Pre-post coaching intervention

Masking: None (Open Label)
Primary Purpose: Other

• Condition: Spinal Cord Injuries

Intervention

Behavioral: strength based coaching

strength based and solution focused coaching

Study Arms

coaching in context

10, 1 hour sessions of face to face strength based coaching sessions provided face to face or over the phone.

Intervention: Behavioral: strength based coaching

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 17, 2023): 9
• Original Estimated Enrollment (submitted: March 29, 2019): 16
• Actual Study Completion Date: November 16, 2019
• Actual Primary Completion Date: November 16, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• female primary caregiver of youth between 6-13 years of age with traumatic spinal cord injury
• female primary caregivers have legal guardianship of their child with spinal cord injury
• speak, read and comprehend English
• be available for face-to-face coaching
• have a cell phone with text messaging capabilities, and willing to utilize cell or land line for coaching and data collection
• able to verbalize changes in their own participation or their child's participation during initial screen
• written consent

Exclusion Criteria:

• severe mental health condition of female caregiver, as documented in child's medical record or reported to research staff by child's treating MD or medical team member
• abuses illicit or prescribed substances or alcohol at time of initial screen as documented in child's medical record or reported to research staff by child's treating MD or medical team member

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: This study is focused on primary female informal caregivers

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03898700
• Other Study ID Numbers: 533863
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Thomas Jefferson University
• Original Responsible Party: Same as current
• Current Study Sponsor: Thomas Jefferson University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: MJ Mulcahey, PhD; Thomas Jefferson University

• PRS Account: Thomas Jefferson University
• Verification Date: April 2023